The American Society of Clinical Oncology (ASCO) today released a position statement on state drug repository programs, outlining ASCO’s support for drug repository programs solely for oral medications provided they are maintained within a closed system. The Society also makes recommendations to help ensure that these programs are implemented appropriately, with sufficient patient protections in place.
Researchers at Memorial Sloan Kettering Cancer Center found that nearly $3 billion is lost annually to cancer drug waste.1 Examples of waste, as described by ASCO members, are when pharmacy benefit managers send an incorrect dosage or type of medication, or medication is sent directly to a patient’s home, only to have it expire before the recipient can use it. Each mistake and wasted prescription for cancer medication creates additional expense for the healthcare system and may delay the start of, or interrupt, necessary treatment for a patient. Unused medications, if maintained within a closed system, can be made available to patients who would not otherwise be able to afford essential cancer medicines.
“Oncologists’ first priority is always to ensure that their patients can access the right treatment at the right time,” said ASCO President Howard A. “Skip” Burris, III, MD, FACP, FASCO. “Unfortunately, for some people with cancer there are significant barriers standing between them and the care they need. Appropriately implemented drug repository programs can help these patients by increasing the supply of lower-cost cancer drug treatments in a manner that helps keep recipients safe.”
Currently, 13 state drug repository programs are available for unused cancer drugs, supplies, and devices. These cancer-specific programs are intended to address prescription drug waste, and ASCO contends that widespread use of such programs could lower costs for patients and payers, improve access to treatment for people who can’t afford high-cost cancer drugs, all while reducing the amount of unused medications in the outpatient setting.
Most drug repository programs exclude controlled substances, expired drugs, and drugs that show any signs of tampering, misbranding, deterioration, compromised integrity, or adulteration. They also typically require drugs to be inspected by a qualified professional prior to being dispensed, and commonly include liability protections for both donors and recipients. State programs do, however, vary with regard to the types of drugs they accept, eligibility criteria for patients receiving donated drugs, and other factors. ASCO's statement includes several detailed tables with state-specific resources on drug repository policies and programs.
A closed system is one in which the delivery and/or return of prescription drugs from a healthcare facility is maintained in a controlled environment under the supervision of a healthcare practitioner and not the patient. In a closed system, the drugs are not handled by anyone other than those explicitly identified in the system. Drug repository programs within a closed distribution system are compliant with Food and Drug Administration policy on returning unused prescriptions, and ensure that the received surplus medicines are administered in a safe, effective, and private manner and can then be dispensed according to the prescribing clinician’s guidance.2
To ensure that state drug repository programs are appropriately implemented, ASCO makes the following recommendations:
- States with no such laws should implement drug repository programs that include liability protections for participants and in accordance with their state health regulatory authority.
- Patients should receive appropriate notification that they are receiving a donated prescription drug.
- ASCO and other professional medical associations should make efforts to educate physicians regarding the existence and value of such programs.
- Drug repository programs should be implemented at no additional cost to the patient beyond a handling fee based on Medicaid’s standard pharmacy dispensing fee.
These recommendations affirm ASCO’s 2017 Position Statement on Addressing the Affordability of Cancer Care Drugs and the Society’s commitment to “supporting and promoting practical policy solutions that ensure patients with cancer have access to--and can afford--drugs vital to the treatment of their disease.” Further, ASCO believes that “any policy solutions to address the price of cancer drugs must promote access to care for patients, affordability of drugs vital to their treatment, and innovation in drug development. Regardless of the specific policy recommendations pursued, defining value must underpin the drug pricing debate.”
1Bach, Peter et al (2016), Overspending driven by oversized single dose vials of cancer drugs BMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i788
2 Food and Drug Administration. Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (CPG 7132.09)